NCT07070986 Randomized, Single-blind Pilot Study Assessing the Effect of Cutaneous RESonance Stimulation SYMPAthetic and Parasympathetic Tone and Anxiety in Patients Admitted for Cardiac Surgery
| NCT ID | NCT07070986 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Anxiety |
| Study Type | OBSERVATIONAL |
| Enrollment | 62 participants |
| Start Date | 2025-09-30 |
| Primary Completion | 2027-03-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 62 participants in total. It began in 2025-09-30 with a primary completion date of 2027-03-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Anxiety is a natural response to stress which peaks just before the surgery procedure. High levels of anxiety can increase postoperative pain and complications. Medicated anxiolysis is no longer recommended, in the absence of proven efficacy. Other interventions to prevent anxiety are required. The autonomic nervous system (ANS), both sympathetic and parasympathetic, determines the response to stress. Anxiety interventions such as hypnosis, massage and relaxation work by modulating ANS tone. The ANS also modulates heart rate. Anxiety can be measured by RR space, from which HRV, high-frequency (HF) and low-frequency (LF) are components respectively linked to the parasympathetic and sympathetic systems. The LF/HF ratio reflects sympathetic dominance if high, and parasympathetic dominance if low. Cutaneous resonance stimulation (RESC) is a manual technique. RESC can diagnose and correct energy imbalances by skin stimulation between two points and thus act on anxiety. We hypothesized that a preoperative RESC session would modify the sympathetic/parasympathetic balance and reduce anxiety in patients admitted for cardiac surgery, compared to patient receiving a sham RESC session: non-specific cutaneous stimulation (NSCS).
Eligibility Criteria
Inclusion Criteria: * Planned cardiac surgery with extracorporeal circulation * Pre operatory anxiety : STAI-E score \>30 or Visual Analogue Scale Anxiety \>6 Exclusion Criteria: * Urgent surgery * Atrial fibrillation * Impossibility to answer to STAI-E or VAS * Use of alternative method * Use of an alternative method other for anxiety before inclusion * Absence of consent * Pregnant, breastfeeding women.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07070986 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07070986 currently recruiting?
Yes, NCT07070986 is actively recruiting participants. Contact the research team at chantal.clement-charrion01@chu-lyon.fr for enrollment information.
Where is the NCT07070986 trial being conducted?
This trial is being conducted at Bron, France.
Who is sponsoring the NCT07070986 clinical trial?
NCT07070986 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 62 participants.
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